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Clinical Trials
Clinical trials are an essential step in bringing a medical device to market. These trials are conducted to gather data on the safety and effectiveness of the device. The data gathered during clinical trials are used to support the safety and effectiveness of the device and are often required by regulatory bodies to clear or approve the device.
Several types of clinical trials are commonly used for medical devices, including:
Feasibility studies: These studies are conducted to determine if a device is technically and clinically feasible. They are typically small, short-term studies that involve a small number of subjects.
Pilot studies: These studies are conducted to gather preliminary data on the safety and effectiveness of a device. They are typically small, short-term studies that involve a small number of subjects.
Pivotal studies: These studies are conducted to gather data on the safety and effectiveness of a device. They are typically larger, longer-term studies that involve a larger number of subjects, and are used to support clearance or approval of the device by regulatory bodies.
Post-approval studies: These studies are conducted after a device has been cleared or approved for commercial distribution. They are used to gather data on the long-term safety and effectiveness of the device and to monitor the device’s performance in the market.
The type and number of clinical trials required will depend on the type of device, the stage of development, and the regulatory requirements of the FDA. Additionally, the cost and duration of the clinical trials can vary greatly depending on the complexity of the device, the number of patients involved, and the number of sites at which the trials are conducted.
Clinical trials for medical devices are typically conducted in accordance with Good Clinical Practice (GCP) guidelines, which are international ethical and scientific quality standards for the design, conduct, and reporting of clinical trials. Trials usually start with a small number of subjects and gradually increase the number of subjects as the study progresses. The studies are conducted under the oversight of an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC) to ensure that the rights, safety, and welfare of the subjects and the integrity of the data are protected. The following documents and information should be submitted to the IRB or IEC for review and approval:
- Protocol: A detailed document that outlines the study design, objectives, inclusion and exclusion criteria, procedures, data collection and analysis methods, and endpoints.
- Investigator’s brochure: A document that summarizes the relevant information about the device, such as the device’s design, preclinical and clinical data, and the results of any previous clinical trials.
- Informed consent form: A document that provides information about the study to potential participants, including the risks and benefits of the study and the subject’s rights.
- Patient information sheet: A document that provides information about the study to potential participants in simple, easy-to-understand language.
- (Lead) Investigator’s CV: A document that provides information about the qualifications, experience, and training of the lead investigator.
- Financial disclosure forms: A document that describes any financial interests or conflicts of interest the investigator may have in the device or the sponsor of the trial.
- Insurance or indemnification information: A document that describes the insurance coverage or indemnification that is in place to protect the subjects and the study staff.
- Study-specific monitoring plan: A document that describes the plan for monitoring the study to ensure that the study is conducted in accordance with the protocol, the GCP, and applicable regulations.
It is important to check with the specific IRB/IEC to determine the specific requirements for submission and to ensure that all necessary information and documents are provided in order to secure approval for the study to proceed.
Resources for Understanding and Preparing Clinical Trial Documents for Medical Devices
There are several resources available to help with understanding what needs to be included in the documents required for a clinical trial, and how to write them:
- International Conference on Harmonization (ICH) guidelines: ICH guidelines provide detailed information on the content and format of the various documents required for a clinical trial, including the protocol, the investigator’s brochure, and the informed consent form.
- FDA guidance documents: The FDA provides guidance documents that provide information on the specific requirements for clinical trials, including the format and content of the protocol, the investigator’s brochure, and the informed consent form.
- Good Clinical Practice (GCP) guidelines: GCP guidelines provide detailed information on the ethical and scientific standards for conducting clinical trials, including the format and content of the protocol, the investigator’s brochure, and the informed consent form.
- Professional organizations: Professional organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and the Medical Device Manufacturers Association (MDMA) provide resources and guidelines for conducting clinical trials.
- Consultants: There are companies and independent consultants who specialize in providing guidance and support for the preparation and submission of clinical trial documents. They can review and provide feedback on your documents, as well as help with the submission process to the IRB/IEC.